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Clinical Trials/NCT03716635
NCT03716635UnknownNot Applicable

Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis

Cairo University0 sites30 target enrollmentStarted: November 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Primary Endpoint
postoperative pain assessed by NRS

Study Overview

Brief Summary

the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

Detailed Description

the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

After determining the eligibility of the patient, the assistant supervisor will be contacted to assign the participant to either the intervention (cryotherapy) or the control (normal saline) groups according to the random sequence generated.

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age between 20-40 years old.
  • Systemically healthy patient (ASA I or II).
  • mandibular first molar teeth with:
  • Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
  • Ability for isolation with rubberdam.
  • Restorable teeth
  • Ability to fill the root canals in single visit treatment.

Exclusion Criteria

  • Teeth without good apical constriction, such as wide or open apex
  • Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
  • Patients having significant systemic disorder (ASA III or IV).
  • Teeth that have :
  • Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability

Arms & Interventions

cryotherapy

Experimental

2.5c cold saline as a final flush after chemicomechanical debridement

Intervention: cryotherapy (Procedure)

normal saline

Other

room temperature saline is used as a final flush after chemicomechanical preparation

Intervention: normal saline (Procedure)

Outcomes

Primary Outcomes

postoperative pain assessed by NRS

Time Frame: up to 48 hrs postoperative pain

Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain" 1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"

Secondary Outcomes

  • amount of analgesics assessed by counting(up to 48 hrs postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Magy Essam Sayed El-Askary

resident at endodontic department cairo university

Cairo University

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